May 9, 2002
The Honorable Yuri Hofman
Superior Court of California
Dept. 19 County of San Diego
325 S. Melrose Vista CA 92083
Re: Case No.: SNA013292
Regarding: Doe v. Blue Cross
Dear Judge Hofman
This docurnent is written in response to Dr. Weisenthal's correspondence dated April 25, 2002, in relation to the above referenced small claims proceeding.
Although Dr. Weisenthal is not the plaintiff in this case, he complained during trial of not having sufficient time to review all the documentation, particularly the Blue Cross Blue Shield Technology Evaluation Center report, which was entered as evidence as partial support of Blue Cross Corporate Medical Policy concerning the assay tests performed by Dr. Weisenthal which are in dispute.
At issue in this case are billings submitted by Dr. Weisenthal for dates of service February 28, 1998, and June 16, 2000. On each of these days Dr. Weisenthal performed a consultation office visit (these were both paid and are not at issue) and the human tumor cell chemotherapy assays. The charge for the assay on February 28 was $1,050.00 and the June 16, 2000 assay charge was $1,100.00, for a total of $2,150.00. These assay charges are only the two claims which were denied as not medically necessary and are in dispute.
At the original hearing, Ms. Doe prayed for $2939.00 and was awarded this amount plus $50.00 costs despite the fact that she was unable to provide documentation supporting the amount of her prayer exceeding the total charge on the two claims in dispute. Because she was awarded an amount far in excess of the total charges on the claims at issue, Blue Cross appealed the decision.
At the hearing the Blue Cross representative explained that Blue Cross has a Corporate Medical Policy which states that the human tumor cell assay is considered not medically necessary. The human tumor cell assay is a test which involves exposing tumor cells to a variety of chemotherapy agents for a prolonged time. The purpose of the test is to attempt to predict the effects of the drugs on the tumors to allow the selection of the most effective drug for the patient. A copy of the Corporate Medical Policy was entered as evidence. In further support of the policy, the Blue Cross representative entered as evidence the Blue Cross Blue Shield Technology Evaluation Center Executive Summary Report which is one of the sources used by Blue Cross in formulating its medical policy.
Dr. Weisenthal objected to the Blue Cross Blue Shield Technology Assessment document as noted in his 18 page letter to the court. However, as noted it is only one of several sources utilized by Blue Cross of California in formulating its Corporate Medical Policy. Blue Cross of California Medical Department develops and implements the Blue Cross Corporate Medical Policy. The purpose of medical policy is to review new technology and procedures to determine if they meet Blue Cross of California's technology assessment criteria.
The Blue Cross representative testified that guidance in developing and validating Blue Cross' Corporate Medical Policy is provided by the Medical Policy and Technology Assessment Committee (MPTAC). The MPTAC consists of approximately 20 physicians, including physicians in active practice as well as academics. MPTAC may invite individuals from both academic and community practice to give presentations and discussions on agenda items. Input from the medical community is encouraged and utilized in developing policies.
In reaching decisions regarding investigational status or medical necessity
of new or existing technologies, the MPTAC makes specific use of Blue Cross
of California technology assessment criteria, which are:
I. The technology must have final approval from the appropriate government regulatory bodies. - This criteria applies to drugs, biological products, devices, and diagnostics.
- A drug or biological product must have final approval from the Food and Drug Administration.
- A device must have final approval from the Food and Drug Administration for those specific indications and methods of use that Blue Cross is evaluating.
- Any approval that is granted an interim step in the FDS regulatory process is not sufficient.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
- The evidence should consist of well designed and well evaluated investigations
published in peer review journals. The quality of the body of studies and
the consistency of the results are considered in evaluating the evidence.
The evidence should demonstrate that the technology can measure or alter
the physiological changes related to a disease, injury, illness or condition.
In addition, there should be evidence or a convincing argument based on
established medical facts that such measurement or alteration affects health
- Opinions and evaluations by national medical associations consensus panels or other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence and rationale.
3. The technology must improve the net health outcome,
- The technology's beneficial affects on health outcomes should outweigh any harmful effects’ on health outcomes.
4. The technology must be as beneficial as any established alternatives.
- The technology should improve the net health outcome as much as, or more than, established alternatives.
5. The improvement must be attainable outside the investigational setting.
- When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy criteria #3 and #4.
6. In addition to the above criteria, Blue Cross of California also may consider the degree of acceptance of a particular medical technology within the organized medical community. The MPTAC also uses extensive computerized literature searches through the National Library of Medicine. It may also use the technology evaluation programs of the Blue Cross Blue Shield Association (see Blue Cross Blue Shield Technology Evaluation document on this assay submitted to the court), the United States Agency for Health Care Policy and Research, the American College of Physicians, and other expert reviews to assist it in forming an opinion.
The MPTAC is in turn supported by a Hematology Oncology Subcommittee (which is comprised of academic and practicing clinical oncologists) to advise it in formulating opinions on oncology issues only. The Hematology Oncology subcommittee utilizes the same technology assessment criteria noted above in formulating opinions on oncology issues. The Committee physicians also draw upon their own expertise, and that of their colleagues to assist them in formulation opinions and recommendations for the MPTAC. The Hematology Oncology Subcommittee also asks for input from the medical community and invites physicians to make presentations and discussions.
Indeed, during review of the medical policy regarding these assays, the Hematology Oncology Subcommittee hosted a presentation by the Medical Director of another laboratory (Oncotech) which performs these assays. The Subcommittee recommended to the MPTAC that these assays were investigational and not medically necessary. The MPTAC accepted the recommendation and the Medical Policy was then formulated.
Even Dr. Weisenthal admitted in court that the assay tests fail some of the criteria noted above. Dr. Weisenthal admitted that this technology does not improve the net health outcome of the patient. In addition, Dr. Weisenthal testified that the technology has not been proven in clinical trials. These admissions support Blue Cross' position that the test is not medically necessary. [n.b. red-colored italics formatting added by Larry Weisenthal; see following discussion]
Since the criteria were not met, the technology was not approved, and was found to be not medically necessary.
Ms. Doe's contract with Blue Cross defines Medical Necessity as:
1. appropriate for the symptoms, diagnosis or treatment of the patient's
2. provided for the diagnosis or direct care and treatment of the medical condition, and
3. within the standards of good medical practice within the organized medical community, and
4. not primarily for the convenience of the patient’s physician or another provider, and
5. the most appropriate procedure, supply, equipment, or service which can be safely provided.
The most appropriate procedure, supply, equipment or service must satisfy the following requirements:
- There must be valid scientific evidence demonstrating that the expected health benefits from the procedure, supply, equipment or service are clinically significant and produce a greater likelihood of benefit, without a disproportionately greater risk of harm or complications, for the patient with the particular medical condition being treated than other possible alternatives;
- Generally accepted forms of treatment that are less invasive have been tried and found to be ineffective or are otherwise unsuitable; and
- For hospital stays, acute care as an inpatient is necessary due to the kind of services the patient is receiving or the severity of the medical condition and that safe and adequate care cannot be received as an outpatient or in a less intensified medical selling.
Dr. Weisenthal states that based on Dr. Mckee's testimony, they have clearly met the above criteria. However, Dr. Weisenthal himself testified that there are no proven clinical trials that shows improvement of the patients net health outcome based on the use of these tests.
The lab services performed by Dr. Weisenthal fail the definition of medically necessary services. There is no scientific evidence demonstrating that the expected health benefits from the procedure, supply, equipment or service are clinically significant and produce a greater likelihood of benefit, without a disproportionately greater risk of harm or complications, for the patient with the particular medical condition being treated than other possible alternatives. (See #5, above of the medical necessity definition)
Ms. Doe's contract with Blue Cross clearly excludes any benefit reimbursement for services deemed not medically necessary.
Dr. Weisenthal's letter to the court also states: "...the attempt to reduce benefits on the grounds that I am a non-participating provider is a blatantly malicious attempt to punish Ms. Doe for taking them to court over their breach of contract." This allegation is untrue. Ms. Doe's Blue Cross coverage provides reduced benefits when using non-participating providers, such as Dr. Weisenthal.
Ms. Doe has been a member with Blue Cross since 1994, on a Prudent Buyer Plan which is known in the industry as a Preferred Provider Organization (PPO). A Prudent Buyer participating physician or hospital contracts with Blue Cross and becomes part of the Prudent Buyer network. Blue Cross members utilize providers who are participating in the network thus ensuring the providers a built in patient base. In exchange, the providers agree to accept a negotiated fee schedule for reimbursement. The fee schedule is a cost containment mechanism designed to restrain rapidly spiraling health care costs. All participating providers have agreed to accept the negotiated rate as covered expense for eligible claims and any charges over the negotiated fee must be written off by the provider. This is the financial incentive to the member for using participating providers. Conversely, if a member chooses a non-participating provider, such as Dr. Weisenthal, there is a financial disincentive in the form of lower reimbursement and a higher out-of-pocket cost to the member.
As the Blue Cross representative testified, the combined total covered expense for the assay tests performed on February 24, 1990, and June 16, 2000, is $515.24, for a nonparticipating physician. A unit value is applied to every procedure code. This unit value is then multiplied by a conversion factor. The conversion factors differ among participating providers and non-participating providers. A higher covered expense is allowed for participating providers than non-participating providers. As the documentation submitted by the Blue Cross representative shows, the total covered expense for the services performed on February 28, 1998, is $350.00. The total covered expense for the services performed on June 16, 2000, is $165.24. The total combined covered expense for both dates of service is $515.24, which would be payable if the service were considered medically necessary.
Dr. Weisenthal argues that Blue Cross is legally wrong in its denial of these tests; in support of that contention he criticizes the Blue Cross Blue Shield Technology Assessment of this test. He says in his letter that the 18 member Blue Cross Blue Shield advisory board has no experts who have submitted tumor specimens to him for analysis; therefore he concludes that they are not qualified to render an opinion on the test. A review of the document - as well as a similar one prepared in 1995- shows that each of the technology assessment criteria utilized by Blue Cross Blue Shield was applied to the assay test, and that each was carefully analyzed. The document also contains an exhaustive list of the outside references used in the review. The conclusion of the Technology Assessment program was that the test did not meet the criteria necessary to establish medical necessity.
Blue Cross' determination that these assays are investigational and not medically necessary is not a cavalier decision. It is a carefully thought out, studied and evaluated medical policy which finds that the use of this assay is not medically necessary because there are insufficient studies showing that patients whose physicians utilize this test to select or not select a chemotherapy have a better health outcome that patients whose physicians do not use the test to select or de-select a chemotherapy agent. In researching this matter, the Hematology Oncology Subcommittee did not find any well documented peer reviewed studies which have satisfactorily met the requirements previously noted, and thus recommended that the assay not be covered. Their recommendation has been accepted by Blue Cross’ Medical Technology Committee and has resulted in the Corporate Medical Policy.
The fact that Dr. Weisenthal does not like or agree with Blue Qross Corporate Medical Policy does not make the policy or Blue Cross' use of it legally wrong. Blue Cross has utilized the input of many practicing oncologists, academics, literature searches, and outside sources including the Blue Cross Blue Shield Association to reach its decisions on these assays. Further, both Dr. Weisenthal and Ms. Doe were aware of Blue Cross' position on this assay test after the first one was performed.
Until peer reviewed studies effectively demonstrate that these assays are effective, improve the net health outcome, are beneficial, show improvement outside the investigational setting, and are generally accepted in the medical community, these assays are considered investigational and not medically necessary. Blue Cross has correctly applied its policy to the claims at issue. The judgment should be overturned on appeal.
If the court finds that benefits are due and owing, they should not exceed those available under Ms. Doe’s plan as argued herein. She has also now asked the court in a letter dated April 22, 2002, for a judgment including an award of costs for the hours of preparation time and review for Drs. Mckee and Weisenthal; no documentation of any of this was provided to Blue Cross to verify its accuracy nor did she testify to this in court. Blue Cross respectfully requests that this be denied. Blue Cross respectfully requests the court to overturn the judgment and uphold Blue Cross' position.
Sincerely, Christopher Loftin
Corporate Legal Assistant